This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for pepgen p-15. This device is intended to be used for intrabony periodontal osseous defects due to moderate or severe peridontitis.
| Device | PEPGEN P-15 |
| Generic Name | Bone Grafting Material, Dental, With Biologic Component |
| Applicant | CERAMED CORP. |
| Date Received | 1999-06-24 |
| Decision Date | 1999-10-25 |
| Notice Date | 1999-11-04 |
| PMA | P990033 |
| Supplement | S |
| Product Code | NPZ |
| Docket Number | 99M-4692 |
| Advisory Committee | Dental |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CERAMED CORP. 12860 West Cedar Drive, suite 108 lakewood, CO 80228 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990033 | Original Filing | |
| S017 | 2010-06-23 | 30-day Notice |
| S016 | 2009-11-09 | 30-day Notice |
| S015 | 2007-08-20 | Normal 180 Day Track No User Fee |
| S014 | 2007-01-16 | Normal 180 Day Track No User Fee |
| S013 | ||
| S012 | ||
| S011 | ||
| S010 | ||
| S009 | ||
| S008 | 2006-08-30 | Normal 180 Day Track No User Fee |
| S007 | 2006-05-22 | Special (immediate Track) |
| S006 | ||
| S005 | 2003-11-12 | Normal 180 Day Track |
| S004 | 2002-04-22 | Normal 180 Day Track |
| S003 | 2002-01-14 | 30-day Notice |
| S002 | 2001-01-02 | Normal 180 Day Track |
| S001 | 1999-11-08 | Normal 180 Day Track |